JLB · Atp And Creatine Kinase (Enzymatic), Creatine
Clinical Chemistry · 21 CFR 862.1210 · Class 1
Overview
| Product Code | JLB |
|---|---|
| Device Name | Atp And Creatine Kinase (Enzymatic), Creatine |
| Regulation | 21 CFR 862.1210 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992140 | PICCOLO METLYTE 7 REAGENT DISC | Abaxis, Inc. | Aug 26, 1999 | SESE |
| K971817 | OLYMPUS CK-MB REAGENT | Olympus America, Inc. | Jun 11, 1997 | SESE |
| K782156 | UNITEST CREATINE KINASE | Boehringer Mannheim Corp. | Mar 2, 1979 | SESE |
Top Applicants
- Abaxis, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Olympus America, Inc. — 1 clearance
